Dyax Phase III hereditary angioedema trial meets end point

The Edema4 trial, conducted under a special protocol assessment granted by the FDA, achieved statistically significant improvements in the intent-to-treat population in primary and secondary endpoints. DX-88 was also found to be well tolerated with no drug-related serious adverse events reported in the Edema4 trial.

The primary endpoint of Edema4, patient reported assessment of individual symptom burden at four hours measured using the mean symptom complex severity score, had a p-value of 0.010. Symptom improvement at four hours measured by a treatment outcome score, a secondary endpoint, had a p-value of 0.003. Other secondary endpoints reported on the proportion of responders and the sustainability and durability of response.

The proportion of patients with successful response at four hours was 93.8% for the DX-88-treated group compared to 58.3% for the placebo group (p=0.001). The proportion of patients maintaining significant improvement in overall response was 43.8% for the DX-88-treated group versus 20.8% for the placebo group (p= 0.022).

Based on the safety and efficacy results from its Edema4 and Edema3 Phase III trials, Dyax intends to submit the last module of its biologics license application to the FDA early in the fourth quarter of 2008.